MAUDE Adverse Event Report: ZIMMER, INC. IMPACTOR FOR USE WITH 40 MM I.D. CUP; INSTRUMENT, HIP

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 07/23/2017

Event Type  malfunction  

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see reports: 0001822565-2017-05566, 0001822565-2017-05567.Concomitant medical products: 00151603040 impactor, lot 62976303, 00151603044 impactor, lot 62171803, 00151603048 impactor, lot 61924297.The device has not been returned for evaluation at this time.Follow up attempts are being done for product return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the instrument is not functioning as intended.No patient consequence was reported and no additional information is available at this time.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No further information available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.As returned, the device exhibits wear & tear to the connecting features.There are particles embedded on the dome.Dimensional measurements are conforming.Device history record (dhr) was reviewed and no discrepancies were found.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: IMPACTOR FOR USE WITH 40 MM I.D. CUP
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6795062
• MDR Text Key: 82714507
• Report Number: 0001822565-2017-05565
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00151603040
• Device Lot Number: 62975383
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 10/05/2017; 05/31/2017; 12/10/2018
• Supplement Dates FDA Received: 11/03/2017; 06/07/2018; 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1